Nutritional support system

ABSTRACT

A nutritional system is disclosed, for delivering a colorant dye to a nutritional fluid that flows through the nutritional system.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefits of provisional applications Ser.No. 60/018,314 filed May 24, 1996, Ser. No. 60/019,205 filed Jun. 6,1996, and Ser. No. 60/038,539 filed Feb. 28, 1997.

FIELD OF THE INVENTION

This invention pertains to a delivery system for delivering anidentifying agent to a nutritional support formulation. This inventionrelates also to a combination comprising the delivery system, areservoir containing a nutritional support formulation and to a dripchamber. The invention pertains additionally to a process of adding anidentifying agent to a nutritional support formulation, and to a methodfor administering a nutritional formulation to a patient.

BACKGROUND OF THE INVENTION

A clinical need exists for: (1) a nutritional system comprising adelivery identification means; (2) for a method for ascertaining if apatient on nutritional support is experiencing medical problemscontemporaneously with the nutritional support; and (3) for a method toensure that a patient is receiving the benefits of nutrition.

Nutritional support is the provision of nutrients to patients who cannotmeet their nutritional requirements by eating standard diets. Forpatients on nutritional support, nutrients may be delivered to thegastrointestinal tract enterally, using oral nutritional supplements,nasogastric and nasoduodenal feeding tubes, and tube enterostomies.Current nutritional support techniques permit adequate nutrient deliveryto virtually any patient.

Nutritional support is indicated for many patients, including patientswith inadequate bowel syndromes, patients with a severe, prolongedhypercatabolic status, patients with extensive burns, multiple traumaand mechanical ventilation, patients requiring prolonged therapeuticbowel rest, patients with a treatable disease who have sustained a lossof over 25% body weight, patients with a functioning gastrointestinaltract (as a supplemental oral diet), and patients with other conditions,such as neurological disorders, recovering from surgery and clinicalconditions, such as malabsorption disorders associated with Crohn'sdisease.

Nutritional support has enjoyed wide acceptance in medicine, and it isused daily in clinics, hospitals and nursing homes. While nutritionalsupport is used to deliver many nutrients, problems are frequentlyassociated with its use. For example, if an attending physician detectsfluid in the lungs of a patient, the physician needs to know the natureand/or the content of the fluid, and consequently sucks fluid from thelungs to ascertain the origin of the fluid, in order to prescribe a modeof treatment. To effect a treatment, it is necessary to know if thefluid is stomach fluid that has been regurgitated up the esophagus andaspirated down the trachea into the lungs, fluid from an internalbleeding source, fluid that is infectious in origin, or fluid from anutritional support system. Nutritional support and internal nutritionalsupport are discussed in Current Medical Diagnosis and Treatment, Lange,pp. 1104-1108 (1996); Textbook of Medicine, Cecil, pp. 1168-1171 (1969);The Merck Manual of Diagnosis and Therapy, pp. 942-949 (1987); andPrinciples of Internal Medicine, pp. 466-472 (1994).

In light of the above presentation, it will be appreciated by thoseversed in the nutritional support art to which this invention pertainsthat a pressing need exists for means for ascertaining the presence of anutritional support fluid administered to a patient to distinguish thenutritional support fluid from biological and infectious fluids. Thepressing need exists, also, for a delivery system that delivers anidentification to a nutritional support fluid that imparts a distinctiveproperty to the nutritional support fluid.

OBJECTS OF THE INVENTION

Accordingly, in view of the above presentation, it is an immediateobject of the invention to provide a nutritional support system foradministering a nutritional formulation to a patient, indicated forbetter health.

Another object of the invention is to provide a nutritional supportsystem comprising a delivery system that delivers an identifying agentto a nutritional support composition.

Another object of the invention is to provide a delivery system thatdelivers an identifying agent to a nutritional support formulation.

Another object of the invention is to provide a nutritional supportsystem comprising a reservoir, a drip chamber, and a delivery system inthe drip chamber for delivering a dye to a nutritional formulation thatenters the drip chamber.

Another object of the invention is to provide a drip chamber forascertaining the flow rate therethrough containing a delivery systemthat makes available a nontoxic dye to a nutritional fluid formulationthat enters and leaves the drip chamber.

Another object of the invention is to provide a delivery systemcomprising a dye for adding to a nutritional formulation.

Another object of the invention is to provide a composition of matterfor use in a delivery system and in a nutritional support formulationsystem.

Another object of the invention is to provide a method for adding meansfor identifying a nutritional support formulation by adding apharmaceutically acceptable dye thereto.

Another object of the invention is to provide a method for adding a dyeto a nutritional support formulation that comprises a reservoir of thenutritional formulation, a drip chamber, and a tube for feeding a personin need of nutritional support.

Another object of the invention is to provide a method for administeringa nutrient to a patient by a nutritional support system.

Other objects, features and advantages of this invention will be moreapparent to those versed in the nutritional support art from thefollowing detailed specification and the accompanying claims.

DISCLOSURE OF EXAMPLES OF THE INVENTION

The following examples are illustrations of the present invention andshould not be considered as limiting the scope of the invention, asthese examples and other equivalents thereof will become apparent tothose versed in the nutritional support art in light of this disclosureand accompanying claims.

EXAMPLE 1

A delivery system for delivering a pharmaceutically acceptable dye to anutritional support formulation is made as follows: First, 250 mg ofFD&C Blue Dye No.1 (Food and Drug Administration, drug and cosmeticacceptable dye) is blended with 145 mg of mannitol, 60 mg of osmoticallyeffective potassium chloride, 15 mg of hydroxypropylmethylcellulose of11,200 number-average molecular weight, and 25 mg ofhydroxypropylcellulose of 40,000 number-average molecular weight, withall the ingredients blended to yield a homogenous mass. Then, ethanol isadded to the mass and the blending is continued for 15 minutes to yielda wet mass. The fresh mass is screened and dried in an oven for 24 hoursat 50° C. to yield granules. Next, the dry granules are mixed with 5 mgof a lubricant, such as magnesium stearate or stearic acid, and pressedinto dye-identification cores to provide the identifying agent. Acompressed core that weighs 500 mg is produced by this example.

Next, the cores are coated with a semipermeable wall. The wall-formingcomposition comprises 20.8 mg of cellulose acetate having an acetylcontent of 39.8%, 4.16 mg of poly(vinyl pyrrolidone) of 40,000number-average molecular weight, and 1.04 mg of polyethylene glycol of3,350 viscosity-average molecular weight. The wall-forming compositionis applied as 4% solid content from an acetone:methanol (80:20 v:v)solution. A pan coater is used to apply the wall around the cores. Thesolvent is evaporated in an oven at 50° C. for 65 hours and cooled to aroom temperature of 72° F. Then, two 25 mil exit passageways are drilledin the wall to yield the delivery system. The delivery system deliversthe pharmaceutically acceptable dye for 24.6 hours.

EXAMPLE 2

The procedure of the above example is followed, with all conditions asdescribed, except in this example the dye is FD&C Blue Dye No. 1 blendedwith a hydroxypropylalkylcellulose of 9,200 to 125,000 number-averagemolecular weight, a hydroxyalkylcellulose of 10,000 to 75,000number-average molecular weight and an osmotic solute, such as osmagentssodium chloride, lithium sulfate, sodium sulfate or urea.

EXAMPLE 3

The procedure of the above example is followed in this example, exceptin this example the FD&C is a member selected from the group consistingof: aniline, nitroso, nitro, azo, oxazin, thiazine, pyrazolone,xanthene, indigoid, anthraquinone, acridine, rosanilin, phthalein andquinoline dyes; and the dye is a member selected from: green, brown,orange, purple, magenta and the like. The amount of dye in a deliverysystem is from 1 to 750 mg.

EXAMPLE 4

The procedure of Example 1 is followed in this example, with thedelivery system delivering the dye to a nutritional support formulation,wherein the nutritional support formulation comprises agastrointestinally acceptable fluid, such as water, an oil, a protein, amineral, a saccharide, and a vitamin. Representative of nutritionalcomponents include: water, maltodextrin, soy protein, sugar, vegetableoil, sodium caseinate, soy fiber, triglyceride, coconut oil, calciumphosphate, tartaric acid, ester of monodiglyceride, ascorbic acid,calcium carbonate, magnesium phosphate, carrageenan, choline chloride,taurine, ferrous sulphate, zinc sulfate, sodium chloride,alpha-tocopherol acetate, niacinamide, calcium pantothenate,beta-carotene, cupric sulphate, manganese sulfate, thiamine chloride,pyridoxine hydrochloride, riboflavin, vitamin A palmitate, folic acid,biotin, potassium iodide, cyanocobalamin and vitamin D. The nutritionalsupport is described in Physicians' Desk Reference, 50th Edition, p.2220 (1996).

EXAMPLE 5

The procedure of Example 1 is followed in this example, wherein theprocedure provides a delivery system comprising 1 to 750 mg of a FD&Cacceptable colorant; 2 to 50 mg of an osmagent, such as an osmoticallyeffective solute selected from the group consisting of magnesiumsulfate, magnesium chloride, sodium chloride, potassium sulfate,potassium chloride, sodium sulfate, lithium sulfate, potassium acidphosphate, calcium lactate, urea, inositol, magnesium succinate, andtartaric acid; 10 to 300 mg of a carbohydrate, selected from the groupconsisting of carbohydrate, monosaccharide, disaccharide,polysaccharide, mannitol, raffinose, sucrose, glucose, fructose,pentose, hexose, and lactose; 1 to 40 mg of ahydroxypropylalkylcellulose carrier for the dye, selected from the groupconsisting of hydroxypropylethylcellulose,hydroxypropylisopropylcellulose, hydroxypropylbutylcellulose,hydroxypropylmethylcellulose, hydroxypropylmethylpentylcellulose andhydroxypropylhexylcellulose; 5 to 75 mg of a viscosity regulating agent,selected from the group consisting of hydroxyalkylcellulose, includinghydroxypropylcellulose, hydroxymethylcellulose, triethylcellulose,diphenylmethylcellulose and hydroxyoctylcellulose; and 0.5 to 10 mg of alubricant, selected from the group consisting of stearic acid, magnesiumoleate, magnesium stearate, calcium stearate, potassium palmitate,sodium stearate, sodium palmitate and lithium oleate; and wherein theexit means in the semipermeable wall for delivering the dye from thedelivery system is a member selected from the group consisting of anorifice, passageway, bore, pore, porous element, hollow fiber, capillarytube, erodible polymer, soluble compound, fluid leachable compound,porous insert, and porous overlay. Passageways and equipment for formingpassageways are disclosed in U.S. Pat. Nos. 3,916,899, 4,063,064,4,088,864, 4,200,098 and 5,252,338.

EXAMPLE 6

A delivery system for delivering a dye-colorant to a fluid nutritionalformulation is made as follows: First, 250 mg of FD&C Blue Dye No. 1 isblended with 145 mg of mannitol, 60 mg of potassium chloride, 15 mg ofhydroxypropylmethylcellulose of 11,200 number-average molecular weight,and 25 mg of hydroxypropylcellulose of 40,000 number-average molecularweight, and all the ingredients are blended to yield a homogenous mass.Then, ethanol is added to the mass and the blending continued to yield awet mass. The wet mass is screened and dried to granules. The granulesare mixed with 5 mg of the lubricant magnesium stearate, and cores arecompressed in a tablet press.

Next, the cores are coated with a semipermeable wall. The wall-formingcomposition comprises 20.8 mg of cellulose acetate having an acetylcontent of 39.8%, 4.16 mg of poly(vinyl pyrrolidone) of 40,000number-average molecular weight, and 1.04 mg of polyethylene glycol of3,350 viscosity-average molecular weight. The wall-forming compositionis applied as 4% solid from an acetone:methanol cosolvent (80:20 v:v). Apan coater is used to apply the wall around the cores. Two exitpassageways are drilled in the semipermeable wall, and then the solventis evaporated in an oven.

Next, the delivery system comprising the semipermeable wall is coatedwith an overcoat. The overcoat comprises a colorant for instant releaseof the colorant into a nutrient fluid. The overcoat comprises 8.8 mg ofFD&C Blue Dye No. 1, 24.2 mg of mannitol, 4.4 mg ofhydroxypropylmethylcellulose of 11,200 molecular weight, and 6.6 mg ofpolyethylene glycol of 3,350 weight-average molecular weight. Thecoating solution comprises 10% solid content in a water solvent. Thesolution is added to a pan coater and the overcoat is coated onto theexterior surface of the semipermeable wall. In a further manufacturingembodiment, the exit passageway can be provided after the overcoat isapplied to the delivery system. The delivery system has a mean releaserate of 9-10 mg/hr for 24.6 hours.

EXAMPLE 7

This example provides a composition of matter comprising a deliverysystem and an enteral nutritional formulation, wherein the deliverysystem comprises an overcoat comprising means for containing andinstantly releasing a colorant to an enteral nutritional formulation,which is coated over a semipermeable wall that surrounds a corecomprising a colorant, with exit means in the wall for delivering thecolorant over a prolonged time to the enteral nutritional formulationthat comprises 12 to 18 g of protein, 7 to 12 g of fat, and 35 to 47 gof carbohydrate, in an aqueous fluid for enteral nutritional support.

EXAMPLE 8

The enteral nutritional formulation according to Example 7, wherein theformulation comprises minerals and vitamins selected from the groupconsisting of calcium, phosphorus, potassium, sodium, chloride,magnesium, iron, zinc, copper, iodine, manganese, chromium, molybdenum,selenium, ascorbic acid, thiamine, riboflavin, niacin, biotin,pantothenic acid, pyridoxine, folic acid, cobalamin, vitamin A, vitaminD and vitamin E.

EXAMPLE 9

The nutritional formulation for enteral administration according toExample 7, wherein the nutritional formulation provides the dailynutritional requirements of minerals and vitamins selected from thegroup consisting of 0.8 to 1.2 g calcium, 0.8 to 1.2 g phosphorus, 2 to5 g chloride, 2 to 5 g magnesium, 7 to 12 g iron, 12 to 18 g zinc, 1 to5 g copper, 0.01 to 0.35 mg iodine, 1 to 7 mg manganese, 0.01 to 0.7 mgchromium, 0.10 to 0.5 mg molybdenum, 0.03 to 0.1 mg selenium, 40 to 80mg ascorbic acid, 0.75 to 1.75 mg thiamine, 0.75 to 10 mg riboflavin, 12to 25 mg niacin, 20 to 80 mg biotin, 1 to 10 mg pantothenic acid, 1 to 5mg pyridoxine, 200 to 600 mg folic acid, 1 to 5 mg cobalamin, 750 to1500 mg vitamin A, 2 to 15 mg vitamin D and 7 to 15 mg vitamin E.

EXAMPLE 10

A nutritional dispensing system comprising means for adding acolorant-dye to a nutrient is provided by a combination comprising areservoir, a drip chamber, and a delivery system in the drip chamber.The reservoir is a container with means for adding a fluid to thereservoir, comprising an outlet means for letting a fluid exit thereservoir, and a capacity of 10 to 50,000 ml. The reservoir can bestructured as a bottle or as a bag. The reservoir can be made of amember selected from the group consisting of glass and plastic.Acceptable materials for providing the reservoir as a flexible plasticbag include a polymer represented by a polyolefin, a polyethylene, apolyvinylchloride and a polytetrafluorethylene. The outlet of thereservoir connects through a releasable tube to a drip chamber. The dripchamber comprises a wall that surrounds an internal lumen with acapacity of 5 to 100 ml, an inlet for letting fluid enter the dripchamber, and an outlet for letting fluid exit the drip chamber. The dripchamber can be calibrated to deliver drops of 5, 10, 15, 20 or more permilliliter that pass through the drip chamber. A feeding tube connectsreleasably to the outlet and carries the nutrient to the patient. Thereservoir and the drip chamber are described in Intravenous Medications,Sager and Bomar, pp. 3-153 (1980), J. B. Lippincott Co.

A delivery system provided by the invention that can be positionedinside the drip chamber comprises a core, comprising 50 wt % of FD&CBlue Dye No. 1, 29 wt % mannitol, 12 wt % potassium chloride, 3 wt %hydroxypropylmethylcellulose of 11,200 molecular weight, 1 wt %magnesium stearate, and 5 wt % hydroxypropylcellulose of 40,000molecular weight; a wall comprising a semipermeable composition of 80 wt% cellulose triacetate, 16 wt % poly(vinyl pyrrolidone), and 4 wt %polyethylene glycol of 3,350 molecular weight; and an overcoat carriedby the semipermeable wall, comprising 20 wt % FD&C Blue Dye No. 1, 55 wt% mannitol, 10 wt % hydroxypropylmethylcellulose, and 15 wt %polyethylene glycol. The dye is delivered through exit means at acontrolled rate of 9.4 mg/hr up to 25 hours to a nutrient as it flowsthrough the drip chamber.

EXAMPLE 11

A delivery system is prepared by following the above example, whereinthe delivery system delivers a pharmaceutically acceptable andnutritionally compatible dye at a release rate of 0.5 to 25 mg/hr over12 to 25 hours, and the semipermeable wall comprises 100 wt % celluloseacylate.

EXAMPLE 12

A delivery system for delivering a pharmaceutically acceptable dye to anutritional support formulation is made according to the above examplesand comprises: 255 mg of a pharmaceutically acceptable dye, 147.9 mg ofa saccharide, 15.3 mg of a hydroxypropylalkylcellulose, 61.2 mg of anosmagent, 5.1 mg of a lubricant, and 25.5 mg of a hydroxyalkylcellulose;a wall comprising 20.8 mg of a cellulose polymer, 4.2 mg of poly(vinylpyrrolidone) and 1.0 mg of a lubricant; and an overcoat consisting of24.8 mg of a carbohydrate, 4.5 mg of a hydroxypropylalkylcellulose, 6.8mg of polyethylene glycol, and 9.0 mg of a nontoxic dye.

EXAMPLE 13

The delivery system according to Example 12, wherein the compositionalcore in the delivery system weighs 510 mg, the wall weighs 26 mg and theovercoat weighs 45 mg.

EXAMPLE 14

A delivery system for delivering a colorant to a fluid nutritionalformulation is made as follows: First, 255 mg of FD&C Blue Dye No. 1 isblended with 147.9 mg mannitol, 61.2 mg potassium chloride, 15.3 mghydroxypropylmethylcellulose of 11,200 number-average molecular weightand 25.5 mg hydroxypropylcellulose of 40,000 number-average molecularweight, with all the ingredients blended to yield a homogenous mass.Then, ethanol is added to the mass and the blending continued to yield awet mass. The wet mass is screened and dried to granules. The granulesare mixed with 5.1 mg of lubricant magnesium stearate, and cores arecompressed in a tablet press.

Next, the cores are coated with a semipermeable wall. The wall-formingcomposition comprises 20.8 mg cellulose acetate having an acetyl contentof 39.8%, 4.2 mg poly(vinyl pyrrolidone) of 40,000 number-averagemolecular weight and 1.0 mg polyethylene glycol of 3,350 weight-averagemolecular weight. The wall-forming composition is applied as 4% solidfrom an acetone:methanol cosolvent (80:20 v:v). A pan coater is used toapply the wall around the cores. Two exit passageways are drilled in thesemipermeable wall, and then the solvent is evaporated in an oven.

Next, the delivery system comprising the semipermeable wall is coatedwith an overcoat. The overcoat comprises a colorant for instant releaseof the colorant into a nutrient fluid. The overcoat comprises 9 mg ofFD&C Blue Dye No. 1, 24.8 mg of mannitol, 4.5 mg ofhydroxypropylmethylcellulose of 11,200 molecular weight, and 6.8 mg ofpolyethylene glycol of 3,350 weight-average molecular weight. Thecoating solution comprises 10% solid content in a water solvent. Thesolution is added to a pan coater and the overcoat is coated onto theexterior surface of the semipermeable wall. In a further manufacturingembodiment, the exit passageway can be provided after the overcoat isapplied to the delivery system. The delivery system has a mean releaserate of 9-10 mg/hr for 24.6 hours.

EXAMPLE 15

A process is disclosed in this example for adding a color to anutritional formulation. The process is as follows: First, areservoir-container, comprising 1,000 ml of an aqueous-based fluidformulation that supplies to a patient 0.8 to 1.5 g/kg of protein (perbody weight), 15 to 175 meg/kg of sodium, 10 to 150 meg/kg of potassium,10 to 175 meg/kg of chloride, 5 to 20 meg/kg of calcium, 5 to 25 meg/kgof phosphorus, 5 to 30 meg/kg of magnesium, 3 to 10 meg/kg of zinc, and0.5 to 15 meg/kg of copper, which reservoir-container is connected inreleasable connection through a tube to the inlet of a drip chamber.Then, a delivery system is added to the drip chamber, the deliverysystem comprising: (1) a core, comprising 20 to 70 wt % of a dye; 10 to40 wt % of a carbohydrate selected from the group consisting of: asaccharide, sucrose, glucose, fructose, mannitol, mannose, galactose,aldohose, aldopentose, allose, altrose, talose, gulose and idose; 2 to30 wt % of a hydroxypropylalkylcellulose of 9,200 to 125,000 molecularweight; 5 to 25 wt % of an osmagent selected from the group consistingof sodium chloride, potassium chloride, magnesium sulfate, magnesiumchloride, potassium sulfate, sodium sulfate, lithium sulfate andmagnesium succinate; 0.5 to 5 wt % of a lubricant such as magnesiumstearate, potassium stearate or stearic acid; and 0.5 to 12 wt % of ahydroxyalkylcellulose of 30,000 to 50,000 molecular weight; (2) a wallsurrounding the core, comprising: 40 to 90 wt % of a member selectedfrom the group consisting of cellulose ester, cellulose ether andcellulose ester-ether, 5 to 25 wt % of poly(vinyl pyrrolidone) of 15,000to 75,000 molecular weight, and 0.5 to 8 wt % of a polyethylene glycolof 2,000 to 5,000 molecular weight; (3) an overcoat, comprising 10 to 30wt % of a dye, 35 to 75 wt % of a carbohydrate, 4 to 18 wt % of ahydroxypropylalkylcellulose of 9,200 to 75,000 molecular weight, and 5to 20 wt % of a polyethylene glycol of 2,000 to 5,000 molecular weight,with the total weight equal to 100 wt %; and (4) an exit orifice throughthe overcoat and the wall for delivering the dye to nutritional fluidflooring through the drip chamber over 24 hours.

EXAMPLE 16

The procedure is followed in the above example to provide a deliverysystem that releases FD&C Blue Dye No. 1 at a rate of 0.14 mg/min over24 hours.

EXAMPLE 17

The procedures of the above examples are followed for providing deliverysystems encompassing all shapes useful for the purpose of thisinvention. The delivery systems provided by this invention comprise aplurality of shapes, including square, rectangular, round, oblong,ellipse, bulbous, bean, tablet and capsule. The delivery system includesany shape that readily lends itself to placement within a drip chamberand permits the free passage or flow of fluid into, through, and out ofthe drip chamber. The delivery system embraces a shape that does notblock the fluid outlet, during use it remains in the drip chamber, itsshape avoids passage into the outlet, and its shape avoids passage intoa patient.

METHOD OF PRACTICING THE INVENTION

The invention provides a method for delivering a formulation comprisinga nutrient and a fluid to a patient in need of a nutritional supportformulation. The method comprises: (A) admitting into thegastrointestinal tract of the patient a nutritional support systemcomprising: (1) a reservoir, comprising an outlet and an inlet, and anutritional formulation comprising a nutrient and a pharmaceuticallyacceptable liquid; and (2) a drip chamber, comprising an inlet and anoutlet, with the inlet releasably communicating through a tube with theoutlet of the reservoir, and the drip chamber outlet releasablycommunicating through a tube with the patient; and (B) administering theformulation comprising the nutrient and the fluid in a beneficiallyeffective amount over a prolonged period of time; and wherein the methodis characterized by (3) a delivery system in the drip chamber that addsa dye to a nutritional formulation that enters the drip chamber, whichdelivery system comprises a core containing 20 to 70 wt % of a dye, 10to 40 wt % of a saccharide, 2 to 30 wt % of ahydroxypropylalkylcellulose, 5 to 25 wt % of an osmagent, 0.5 to 5 wt %of a lubricant, and 0.5 to 12 wt % of a hydroxyalkylcellulose; a wallthat surrounds the core and comprises 40 to 90 wt % of a cellulosepolymer, 5 to 25 wt % of a poly(vinyl pyrrolidone) and 0.5 to 8 wt % ofa polyethylene glycol, and an exit in the delivery system for deliveringthe dye to formulation that enters the drip chamber.

The invention provides for the use of a nutritional support system foradministering a nutritional formulation to a patient, wherein thenutritional system comprises: (A) a reservoir, comprising a wall thatsurrounds an internal lumen, with an outlet in the wall for letting anutritional formulation leave the reservoir; (B) a drip chamber,comprising an internal lumen with an inlet and an outlet, with the inletreleasably connected to the outlet of the reservoir; and (C) conveyingmeans releasably connected to the outlet of the drip chamber forconveying a nutritional formulation to the patient; and wherein thereservoir is characterized by containing a nutritional formulationcomprising water, proteins, minerals, saccharides and vitamins; and thedrip chamber is characterized by containing a delivery system comprisinga dye, an osmotically active compound, and a member selected from thegroup consisting of a hydroxyalkylcellulose and ahydroxypropylalkylcellulose; a wall comprising a cellulose polymer; andan exit in the delivery system for delivering the dye to the nutritionalformulation that enters the drip chamber.

The above disclosure and examples present the invention forgastrointestinal administration of a nutritional support formulation.The invention, however, embraces adaptations of the nutritional supportsystem for administering a nutritional support formulationintravenously, parenterally, and intraperitoneally.

The present invention provides many advantages to the nutritional art asdescribed in the accompanying specification. Obviously, manymodifications and variations of the instant invention are possible inlight of the above specificity, and it is therefore to be understoodthat within the scope of the disclosure and the appendix claims, theinvention may be practiced otherwise then is described specificallyherein.

What is claimed is:
 1. A drip chamber comprising: a wall that surroundsan internal space: an inlet for admitting a nutritional formulation intothe drip chamber, and an outlet for letting the nutritional formulationleave the drip chamber: a delivery system in the internal space fordelivering colorant dye into the nutritional formulation comprising acomposition comprising: 20 to 70 wt % of a dye suitable for deliveringcolorant into said nutritional formulation, 10 to 40 wt % of acarbohydrate, 2 to 30 wt % of a hydroxypropylalkylcellulose of 9,200 to125,000 molecular weight, 5 to 25 wt % of an osmagent, 0.5 to 5 wt % ofa lubricant, and 0.5 to 12 wt % of a hydroxyalkylcellulose of 30,000 to50,0000 molecular weight; a wall that surrounds the composition andcomprises 40 to 90 wt % of a member selected from the group consistingof a cellulose ester, cellulose ether and cellulose ester-ether, 5 to 25wt % of a poly(vinyl pyrrolidone) of 15,000 to 75,000 molecular weight,and 0.5 to 8 wt % of a polyethylene glycol of 2,000 to 5,000 molecularweight; and overcoat on the wall comprising 10 to 30 wt % of a dye, 35to 75 wt % of a carbohydrate, and 4 to 18 wt % of ahydroxypropylalkylcellulose of 9,200 to 75,000 molecular weight and 5 to20 wt % of a polyethylene glycol of 2,000 to 5,000 molecular weight; andexit means in the delivery system for delivering the composition over aprolonged period of time.